Advanced Lung Cancer, Chemotherapy, Precision Cell Immunotherapy
Conditions
Keywords
Precision Cell Immunotherapy, Chemotherapy, Advanced Lung Cancer
Brief summary
To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer. Eligibility: Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.
Detailed description
A total of 40 patients may be enrolled over a period of 1-2 years.
Interventions
DRUGChemotherapy
Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
BIOLOGICALPrecision Cells
Precision Cells DC cell suspension (1×10\*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
Sponsors
Ningbo Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 65 years old, male or female; 2. Life expectancy≥6 months; 3. ECOG score: 0-3; 4. Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians; 5. Enough venous channel, no other contraindications to the separation and collection of white blood cells; 6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x10\*/L,hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level； 7. Signed informed consent； 8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cells transfusion.
Exclusion criteria
1. Expected Overall survival \< 6 months; 2. Patients with uncontrolled hypertension (\>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months. 3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc; 4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month. 5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | 2 years |
| Progress-free survival | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 2 years | Questionnaire will be used. |
Countries
China
Contacts
Primary ContactBi Wang
Outcome results
None listed